U.S. Food and Drug Administration
FDA Consumer magazine
September-October 2002
Table of Contents

The Last Word

FDA: A Science-Based Agency

By Daniel A. Casciano, Ph.D.

The National Center for Toxicological Research (NCTR) is one of six centers within the FDA. It is the only center that does not have consumer product regulatory authority. Our primary function is to develop and modify standards that can be applied in the regulatory environment and to anticipate future research needs of the FDA. We are sometimes asked why the FDA does research, because it is generally recognized that research is the purview of the National Institutes of Health (NIH). The NIH supports "basic research," that is, new knowledge that may or may not have a direct impact on protecting the public health.

Research done at the NCTR and other FDA centers is "translational" in nature. This means that basic information derived from an NIH-sponsored study is further modified to apply to a specific question that is relevant to the FDA's mandate to protect the public health. An example of this is the basic research developed to create a mutant mouse or rat. FDA scientists use the technology and apply it to specific mouse or rat strains to help them assess the safety of a human or animal drug, or to understand the mechanism of action of a particular food additive or medical device. Sometimes the conversion of basic information to applied information that would be useful to the FDA takes several years.

The article "Food Freshness and 'Smart' Packaging," in this issue of FDA Consumer, is an example of the journey of an FDA scientist's idea as it wends its way toward consumer use. The scientist, Dwight Miller, Ph.D., was asked to determine whether the odors released from new carpeting may be harmful to the consumer. Using methodology developed from basic research, he first identified the chemical class that was entering the vapor phase and sensitizing our sense of smell. Upon identification of the chemical class, he reasoned that these chemicals are similar to those emitted by decomposing fish. Realizing the direct application of this information to a consumer need, he set out to develop the "food quality indicators" described in the accompanying article (see page 25). Progressing from the initial idea to the present encompassed several years. However, the effort was well spent because he is now working on technologies that can detect spoiling beef and poultry. In another seemingly unrelated twist, Miller also is using the applied knowledge to identify the presence of explosives. These efforts have the potential of being beneficial to consumers.

Other translational research efforts ongoing at the NCTR include:

development and modification of research standards by which those involved in toxicological research can identify cancer-causing agents in model animal systems
assessment of potential toxic reaction of sunlight and cosmetics or some dietary supplements on the skin of model animal systems
development of tools that will help identify certain populations at risk to products regulated by the FDA using technologies that were derived from the sequencing of the human genome (a process funded by the NIH)
evaluation of specific anti-viral strategies developed through NIH funding to prohibit the transmission of the HIV virus to offspring of infected females.
FDA employees are proud to be in a science-based agency whose decisions are supported by sound science. A strong scientific presence within the FDA is represented by regulatory reviewers and scientists who have:
state-of-the-art scientific knowledge within their specific disciplines
access to the latest scientific knowledge and instrumentation so that an enforcement decision results from risk-benefit judgment, balancing the safety of the public health and the potential economic impact of the decision, and
the task of developing and validating scientific methods as well as anticipating the FDA's future research needs.

It is extremely important that the FDA maintain its ability to make quality decisions based on sound science. This is more important now because of the quickened pace of discovery by the industries that the FDA regulates. In order to avoid becoming a bottleneck to the process of moving these newly developed products to the consumer, a strong internal scientific presence is essential in the FDA.

Daniel A. Casciano, Ph.D., is director of the FDA's National Center for Toxicological Research.